Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-03-13 @ 3:08 AM
Study NCT ID:
NCT02732951
Status:
COMPLETED
Last Update Posted:
2019-03-20
First Post:
2016-04-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Effect on Central Retinal Thickness of BI 1026706 in Patients With Diabetic Macular Edema
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
A Randomized, Double-masked, Placebo-controlled Exploratory Study to Evaluate Pharmacodynamics, Safety and Tolerability of Orally Administered BI 1026706 for 12 Weeks in Patients With Mild Visual Impairment Due to Center-involved Diabetic Macular Edema (DME)
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a proof of mechanism trial to explore the effect of BI 1026706 on the central retinal thickness and to evaluate safety and tolerability of BI 1026706 administered orally for 12 weeks in patients with mild vision impairment due to center-involved DME
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2015-003529-33 | EUDRACT_NUMBER | None | View |